3. MDE Advisory Committee Approach

The MDE Advisory Committee first met in late September 2012, and it finalized its recommendations at a meeting in early May 2013. An Editorial Subcommittee drafted this report; the full Committee requested revisions after its review in mid-June 2013 (teleconference). The full Committee approved the revised report in mid-September 2013. Section 3 summarizes the activities of the MDE Advisory Committee during this 12-month period, the processes and information Committee members used to make their decisions, and the challenges Committee members confronted in producing their recommendations for accessibility standards. Committee members represented a range of organizations (Table 1.2) that have diverse but specific interests in the accessibility of MDE to individuals with disabilities. The diversity of these stakeholder representatives offered critical value to the Committee’s deliberations, giving voice to a variety of viewpoints and educating all members about issues beyond their own particular purviews. In addition, because many Committee members are knowledgeable in their specific areas, they were able to draw from their own expertise and experience to inform the decision-making.

3.1 Refining MDE Definition and Committee Scope

As noted in Section 1.1, the statutory authority of the MDE Advisory Committee limited its scope to medical equipment used for diagnostic purposes by adults. Therefore, from the outset, Committee members recognized that their deliberations would exclude considerations relevant to children and youth and medical equipment used for therapeutic or treatment purposes only rather than diagnostic testing (see Sections 7.1 and 7.2). Although differentiating between equipment intended for diagnostic versus therapeutic uses seems initially straightforward, during the first meeting (September 27-28, 2012), Committee members raised concerns about the exact equipment encompassed by MDE. These comments posed examples of types of equipment where this distinction between diagnostic and therapeutic purposes seemed ambiguous. Therefore, the Committee began its activities by first addressing the critical question that would circumscribe its future deliberations: What is medical diagnostic equipment?

To identify the various categories of MDE, Committee members conducted an exercise aimed at eliciting a comprehensive listing of medical diagnostic equipment types. Table 3.1 lists the equipment types mentioned during this exercise. Although the vast majority of this equipment fit squarely within a general understanding of “medical diagnostic equipment,” some items (marked with a superscript “a” on Table 3.1) appeared more ambiguous or their applicability for the proposed rules seemed unclear. Examples of considerations raised by equipment marked with the superscript “a” include the following:

Table 3.1

MDE Advisory Committee Preliminary List of
Potential Medical Diagnostic Equipment Types

Examination tables configured as tables
Examination tables, configured as chairs
Acupuncture tables
Angiography tables
Cardiac catheterization tables
Chiropractic tables
Cystoscopy tables
“General use” procedure tables a
Gynecology tables
Massage therapy tables a
Operating room tables a
Rehabilitation therapy tables
Stereotactic breast biopsy tables
Tilt tables for syncope testing
Urodynamics tables
Stretchers/gurneys a
Audiology testing booths
Dental chairs
Dermatology chairs
ENT (ear, nose, and throat) exam chairs
Chairs for upper gastrointestinal studies
Mammography positioning chairs
Ophthalmology exam chairs
Phlebotomy chairs
Podiatry chairs
Dialysis chairs a
Infusion chairs a
Couch in mental health clinician’s office a
Beds a
Beds with radiolucent components
X-ray tables
CT (computed tomography) equipment
MRI (magnetic resonance imaging) equipment
Mammography equipment
Nuclear medicine equipment
PET (positron emission tomography) equipment
Combined PET/CT
Combined PET/MRI
SPECT (single-photon emission computed tomography)
Ultrasound equipment a
Echocardiogram equipment
Equipment for barium studies of gastrointestinal tract
Dental panoramic x-ray equipment
DEXA scanning equipment
Weight scales
Treadmill for exercise stress testing a
Stationary bicycles for exercise testing a
Pulmonary function test equipment a

a Equipment types discussed to determine whether covered by proposed accessibility standards

During the initial Committee exercise mentioned above (to identify potential MDE types), Committee members explained their rationales for including or excluding various categories of equipment. Examples of this discussion include the following:

  • Persons undergoing hemodialysis often sit in chairs configured to facilitate circulatory system access (e.g., through an arteriovenous fistula) and ensure patient comfort and safety during the procedure. Hemodialysis is explicitly therapeutic (i.e., a treatment). However, over the course of dialysis sessions, which can last for several hours, patients are monitored to identify potential complications that require immediate attention. This monitoring could be viewed as diagnostic.
  • Operating room tables are typically used for surgeries that definitively treat or significantly palliate disease. However, surgery can be required to make a diagnosis (e.g., to get tissue for pathological evaluation to determine the presence of cancer). Sometimes operations that begin with therapeutic intent conclude as diagnostic or prognostic (e.g., operations aiming to remove cancerous tumors end when surgeons find the tumor has spread too widely to remove; in these situations surgeons often close the incision, having found evidence that will inform the patient’s cancer prognosis). Whether for therapeutic or diagnostic surgery, however, virtually all patients are transferred onto the operating room table by clinical staff from a stretcher after being transported from a pre-operative area where they likely received initial sedation. Since almost no patients get themselves onto operating room tables, it is not necessary to produce accessibility standards for tables in sterile operating room settings.
  • Stretchers or gurneys are typically seen as transport equipment, used to move recumbent patients within inpatient facilities, emergency departments, and other health care delivery settings where patients require supine transport. Although clinical personnel frequently transfer patients to stretchers,U in many instances patients get onto stretchers independently. Furthermore, sometimes patients undergo extensive diagnostic evaluations while on these stretchers (e.g., in emergency departments). Differentiating stretchers used exclusively for transportation versus diagnostic evaluation is possible. But questions arise about the practicality of having different types of stretchers with different capabilities in busy health care institutions where efficiency and ease of use are at a premium.
  • Hospital beds serve the same basic function as do ordinary beds, but these beds often have specific features to address needs of both patients and staff (e.g., controls to raise and lower the head and foot areas, controls to raise and lower the height of the entire bed, mattresses with circulating air to prevent pressure ulcer development). Patients lying in hospital beds sometimes receive diagnostic testing: routine phlebotomy is a common example. But overall, relatively little diagnostic testing is performed while patients are in hospital beds.
  • To get ultrasound testing or pulmonary function testing, patients must have access to the equipment. But often the ultrasonography or pulmonary function testing equipment is in a unit next to the table, stretcher, or chair where the patient is lying or sitting. In these circumstances, the focus should be on accessibility of the table, stretcher, or chair rather than on the MDE itself. For instance, the ultrasound transducer is easily moved to the patient, wherever the patient is.
  • Exercise stress testing equipment, such as treadmills or stationary bicycles, are used for diagnostic purposes (i.e., to diagnose potential coronary insufficiency, angina, or other heart ailments). However, it is questionable whether this testing would be used for persons with physical disabilities who would not be able to perform the required physical activities (walking or jogging on the treadmill, riding the stationary bicycle). For some patients, stimulating cardiac stress through other forms of exercise (e.g., hand cycles) might be possible. But there are a variety of ways to diagnose coronary artery disease for all patients, regardless of disability. For each individual patient, regardless of disability, a variety of factors might affect the choice of diagnostic tests.V These decisions are made by patients in consultation with their physicians and reflect individual personal and clinical circumstances and patients’ preferences.

Although this “naming” exercise helped clarify the potential range of MDE, Committee members still felt they needed more explicit guidance to define MDE appropriate for setting accessibility standards. A subgroup of Committee member agreed to develop a screen for identifying MDE for making accessibility standard recommendations, which they presented at the outset of the second day of the September 2012 meeting. They started with the definition of “medical device” used by the Food and Drug Administration (FDA, Box 3.1). The proposed screen for MDE for Committee consideration has five components as follows:

  1. Is the product a medical device?
  2. According to its Instructions for Use (IFU), does the medical device perform a diagnostic function?
  3. Must patients interact physically with the medical device in order for the device to perform its diagnostic function?
  4. Must the medical device interact physically with patients (e.g., support the entire patient or anatomical regions of the patient) in order for it to perform its diagnostic function?
  5. Is there an equivalent means of facilitation that meets current standards of care for performing the diagnostic test?

Questions 1-4 must be answered in the affirmative and Question 5 must be answered in the negative for a product to be considered under the requirements of the proposed rule.

Throughout the remainder of its tenure, the Committee continued to discuss the applicability of certain equipment types for the accessibility standards.W The general sense of the Committee was that the standards they recommend (Section 5) cover the vast majority of MDE. Nonetheless, certain specific types of MDE might need additional attention in future rulemaking about accessibility standards (Section 8.2).

Box 3.1

Food and Drug Administration Definition of Device

Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with micro-chip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and postmarketing regulatory controls. A device is:

  • "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
    • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
    • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
    • intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

This definition provides a clear distinction between a medical device and other FDA regulated products such as drugs.

SOURCE: U.S. Food and Drug Administration http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm, accessed May 31, 2013.

3.2 MDE Advisory Committee Process

The MDE Advisory Committee met six times (two days/meeting) in person at the U.S. Access Board offices in Washington, DC, and one time by teleconference (to discuss this report). Committee members and the public who could not attend meetings in person participated via teleconference. All dates and times of full Committee meetings were published in the Federal Register. In the last hour of each meeting day, the Committee sought and received comments from the public.

The original intent had been for the Committee to “hold no more than four meetings and present a report with its recommendations to the Access Board within two months of the Committee’s first meeting" (77 FR 39656 published July 5, 2012). However, as the Committee’s deliberations got underway, it soon became apparent that the complexity of the task – especially the wide range of MDE types that required discussion – demanded additional time. The Committee submitted its report to the U.S. Access Board ten months after its initial meeting.

To move the work forward, in Month 4 the Committee established five Subcommittees and later a working group, the Editorial Committee, to draft the final report. The five main Subcommittees were organized around broad categories of MDE (Table 3.2). Subcommittees included MDE Advisory Committee members and individuals from the public who volunteered to join given their special interest and expertise in the topic area. All Subcommittee meetings were conducted by teleconferences, with meeting dates and times also announced on the Access Board Web site. In totality, the 5 medical equipment subcommittees met 24 times (Table 3.2). Subcommittee chairpersons presented reports about subcommittee deliberations at the last two full Committee in-person meetings and solicited comments from all Committee members. The Subcommittees issued Reports about their deliberations and recommendations and they are provided as supporting materials to this report. Although Subcommittees recommended accessibility standards, the full Committee made all final decisions about these recommendations after deliberation.

The Editorial Committee served as a working group to draft, compile, and edit the final report. Membership was drawn from the Advisory Committee and represented the primary stakeholder interests. The Editorial Committee met 13 times under the leadership of Lisa I. Iezzoni, Boston Center for Independent Living, to review drafts and finalize the report.

As shown in Table 1.2, the MDE Advisory Committee included representatives from a range of stakeholder organizations. Section 3.3 describes in greater detail the information Committee members used to inform their decision-making, but the first resource was the expertise of Committee members themselves. The Committee aimed through discussion to represent varying viewpoints but then aimed for consensus in making recommendations for the accessibility standards. The Committee did not take explicit votes about different options for standards where members held a range of opinions. Instead, to understand better the differing perspectives, the Committee sometimes asked all members to express their preference and the rationale for their choice. In all cases except one – the minimum height of transfer surfaces – the Committee reached consensus on the recommended accessibility standards (see Section 5). The range of options and opinions for the minimum transfer surface height standard are presented in Section 6.

Given its time constraints, the Advisory Committee chose not to address certain topics mentioned in the NPRM that generated relatively few divergent public comments or that seemed to be of lower priority than other provisions of the proposed standards being considered. Recommendations appear in this report (Section 5) only for those topics determined to need revision by the Advisory Committee.

Table 3.2

MDE Advisory Committee Subcommittees, Chairpersons, and
Number of Meetings

Topic Chairperson # of Meetings
Examination Tables and Chairs Kleo King, United Spinal Association 6
Stretchers Renée Kielich, Hill-Rom Company 5
Imaging Equipment John Jaeckle, General Electric Healthcare 4
Mammography Carol Bradley, Sutter Health 5
Weight Scales June Kailes, Harris Family Center for Disability and Health Policy at Western University of Health Sciences 4



3.3 Data Sources

As noted above, MDE Advisory Committee utilized their own expertise in deliberations about accessibility standard specifications. Early on, it became clear that some Committee members were unfamiliar with issues raised during transfers from a wheelchair or scooter onto a surface such as an examination table. To educate their colleagues, several Committee members shared videos from their own research or organizations to provide general experiential information about transfers. In addition, Committee members who use wheelchairs or scooters sometimes raised considerations from their personal experiences obtaining health care services.

The Committee also aimed to support their recommendations with as much scientific evidence as possible. In instances where data were either missing or inconclusive, they sought additional expert opinion. As appropriate and relevant, the Committee also aimed to make their recommendations consistent with previous guidelines and standards set by the U.S. Access Board and made enforceable by the U.S. Department of Justice’s issuance of regulations comprising the guidelines or standards. Access Board staff and some Committee members brought pertinent existing accessibility standards, such as the 2010 ADA Standards for Accessible Design, to the attention of the full Committee. The subsections below describe specific sources of information used by the Committee.

3.3.1 Research Data

MDE Advisory Committee members worked with U.S. Access Board staff to find as many studies as possible that were relevant to various accessibility standards. They relied most heavily upon the work of the Center for Inclusive Design and Environmental Access (IDeA) at the State University of New York at Buffalo, which had conducted the Anthropometry of Wheeled Mobility (AWM) Project. This anthropometric study of 500 persons who use wheeled mobility devices (WMD) involved collection of demographic data, information on WMD characteristics, and structural and functional anthropometry measures. To inform the MDE Advisory Committee, U.S. Access Board staff asked Clive D’Souza and Edward Steinfeld to reanalyze the AWM Project data to examine the adequacy of proposed transfer surface dimensions (30” x 15”) as a static seating surface. Dr. Steinfeld presented their findings at the Committee’s second meeting, and he made himself available to answer Committee and Subcommittee (Examination Tables and Chairs) questions over subsequent months. As mentioned in descriptions of the rationale for various standard recommendations, the Committee found the IDeA data to be very helpful. However, as noted by Dr. Steinfeld, a limitation for the Committee’s purpose was that the AWM Project evaluated only static measures (i.e., persons seated in WMD) rather than examining the active process of transferring from a WMD to another surface, the focus of the Committee’s recommendations.

The Committee also considered findings from University of Pittsburgh study that looked at transfers, specifically at how different conditions affected the abilities of WMD users to transfer from their WMD to another surface. (This study, “The Impact of Transfer Setup on the Performance of Independent Transfers: Final Report,” from the Human Engineering Research Laboratories, VA Pittsburgh Healthcare System, University of Pittsburgh, had been presented at the US Access Board meeting in Washington, DC on July 11, 2011.) University of Pittsburgh investigators have strong collaborations with Department of Veterans Affairs health care providers and groups affiliated with paralyzed veterans’ organizations, so not surprisingly 88 study subjects were men and 24 were women; 54 had spinal cord injuries (another 4 had spinal cord injury plus another condition). Thus, the study subjects do not reflect the general population of persons who use WMD. Nevertheless, the research provided useful insights about how various features of the transfer setting, including gaps between the transfer surface and the WMD, differences in height, and availability and positioning of supports, affect the ability of WMD users to transfer.

For additional guidance, some Committee members referred occasionally to: The Measure of Man and Woman: Human Factors in Design, Revised Edition, Alvin R. Tilley (Henry Dreyfuss Associates), Wiley (John Wiley & Sons, Inc.) 2001; and The Rules of Work: A Practical Engineering Guide to Ergonomics, Second Edition, Dan MacLeod, CRC Press, 2002.

3.3.2 Experienced Clinicians

Although the studies offered helpful data, the Committee felt strongly that it would be useful to hear perspectives from clinicians with extensive experience with persons with disabilities about the process of transferring patients from wheelchairs or scooters onto medical equipment. In response, U.S. Access Board staff invited seven clinicians to make presentations at the Committee’s third meeting. Table 3.3.2 lists the names, clinical disciplines, and affiliations of these experienced clinicians.

Table 3.3.2

Clinicians Who Presented to the MDE Advisory Committee

Name Affiliation Discipline
Barbara Ridley Alta Bates Summit Medical Center RN, FNP
Cathy Ellis National Rehabilitation Hospital PT
Michael Yochelson MedStar National Rehabilitation Network MD
Lauren Snowden Kessler Institute for Rehabilitation PT, DPT
Nüket Curran UPMC Centers for Rehabilitation Services PT
Douglas Coldwell University of Louisville MD
Theresa Branham American College of Radiology RT, ARRT

 

At the Committee’s request, U.S. Access Board staff asked these clinicians to comment on topics primarily related to transferring patients and the implications for recommendations relating to transfer surfaces. The following request was sent to the clinical speakers to formulate their comments to the Committee:X

  • Committee members want to learn about common transfer methods, including information about mobility device positioning, transfer techniques, and transfer aids.
  • Committee members are deliberating how wide the portion of an exam table surface onto which patients transfer must be (defined as a “transfer surface”). The Committee is considering two main options: minimum widths of 28” or 30”. “Tables” are equipment used by patients in supine, prone, or side-lying positions.
  • Committee members are considering the same transfer width issue for exam chairs. Because exam chairs have up-right back support, armrests, and patients do not typically need to reposition their entire body once on the equipment, a narrower minimum width of 21” is proposed. Committee members are deliberating whether this width requirement should be the same as or less than table type equipment discussed above (28” or 30”).
  • The Committee has agreed that transfer surfaces (for both tables and chairs) should be adjustable in height and is now determining the height ranges that must be provided. Committee members are considering two low height options: 17” or 19”. Competing concerns involve not excluding patients in wheelchairs with low seat heights and equipment features/mechanisms that would be difficult or costly to position underneath an exam surface height of less than 19”.
  • Committee members will shortly consider what kind of supports (handholds, rails, etc.) tables and chairs should have to facilitate transfers and whether these supports should be positioned at particular locations on/around the exam surface. These deliberations will include discussions about the position (horizontal, angled, or vertical), length, gripping shape, and distance above and from the transfer surface.

The clinicians’ presentations were timed so that Committee members would have ample chance to ask them questions. As noted in Sections 5 and 6, the opinions of these experienced clinicians figured prominently in some Committee recommendations. An obvious limitation of their contributions is the relatively small number of clinicians and lack of representation from a full range of clinical disciplines.

3.3.3 Presentations about MDE Types

Committee members representing two stakeholder groups – manufacturers of imaging equipment and examination tables and chairs – requested the opportunity to make presentations before the Committee. The imaging presentation occurred at the third meeting and the presentations about examination tables and chairs at the fourth meeting (Table 3.3.3). Both sets of presentations highlighted technological considerations specific to these broad categories of MDE. This material is described further in Section 4.3 (imaging equipment) and Section 4.1 (tables and chairs). Committee members had ample time to ask questions and discuss the implications of the issues presented for making the accessibility standard recommendations.

Table 3.3.3

Manufacturing and Engineering Representatives
Who Presented to the MDE Advisory Committee

Name Affiliation Position
Willa Crolius Institute for Human Centered Design Coordinator of Public Programs
Michelle Lustrino Hologic, Inc. Mechanical Engineer
Glenn Nygard Hologic, Inc. Senior Principal Engineer
Elisabeth George

Philips Healthcare

MITAY

Vice President of Global Regulations and Standards
Chair of Technical and Regulatory Affairs Committee

John Jaeckle GE Healthcare
MITA
Chief Regulatory Affairs Strategist
Chair of CT─X-ray Committee
John Metellus Siemens Healthcare Product Marketing Manager
Bob Menke Midmark Corporation Engineering Manager
Jon Wells Midmark Corporation Vice President of Marketing
Jeff Baker Medical Technology Industries, Inc. President
Brad Baker Medical Technology Industries, Inc. Executive Vice President
Darren Walters Medical Technology Industries, Inc. Engineering Manager

  

Notes

S Similarly, individuals receiving chemotherapy (treatment) may sit for many hours in infusion chairs, which have the capability of tilting the back support and raising lower leg supports. During these infusions sessions, the patients are monitored closely to detect (diagnose) any infusion reactions or other difficulties.

T Operating rooms are sterile environments where access and activities are carefully controlled to avoid contamination. Surgeons, anesthesiologists, nurses, and other operating room staff only enter the OR covered in sterile paper gowns and caps; persons touch the patients only with gloved hands, following intensive cleansing.

U For instance, when patients are severely ill and need to be transported within a facility, staff will transfer them from their beds to the stretcher.

V A variety of clinical and other considerations affect the choice of diagnostic testing for coronary artery disease, including: urgency (e.g., imminent threat of a heart attack); prior history of cardiac disease and coronary interventions; comorbid health conditions; other health risk factors; the availability of testing facilities; and patients’ preferences. The Advisory Committee did not consider the relative effectiveness of these different diagnostic approaches.

W The proposed standards do not cover a few categories of equipment that may assist persons with disabilities in transferring onto or off of medical diagnostic equipment. Ancillary equipment, such as cushions, bolsters, straps, or sliding boards, can be used to facilitate transfers and to help position patients on medical diagnostic equipment. Lifts also can be used for transfer, although transfers performed with lifts are not independent. Because ancillary equipment and lifts do not perform any diagnostic function, they are not covered by the proposed accessibility standards.

X The text below is what was sent to the clinician speakers. Please note that the language (e.g., about the two low options for transfer surface height) reflects the Advisory Committee’s activities and thinking at the time of the request to the clinician speakers.

Y MITA is the Medical Imaging & Technology Alliance, a division of the National Electrical Manufacturers Association